MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-03 for MINI MAM FAN 678 030690910 manufactured by Ross Laboratories.
[2005]
A newborn was lying in crib on abdomen; head to side with pacifier in mouth. Infant put left ring finger through one of the holes in the white plastic sheild of the pacifier. When discovered the finger was swollen & nurses had to use lotion to get finger outdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, use of all similar devices stopped permanently. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4465 |
| MDR Report Key | 4465 |
| Date Received | 1993-02-03 |
| Date of Report | 1993-01-29 |
| Date of Event | 1992-10-29 |
| Date Facility Aware | 1992-10-29 |
| Report Date | 1993-01-29 |
| Date Reported to Mfgr | 1992-10-30 |
| Date Added to Maude | 1993-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI MAM |
| Generic Name | PACIFIER |
| Product Code | FNN |
| Date Received | 1993-02-03 |
| Model Number | FAN 678 |
| Catalog Number | 030690910 |
| Lot Number | 67041Q6 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-OCT-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4185 |
| Manufacturer | ROSS LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-03 |